Apparatus for extracting fluids

ABSTRACT

An apparatus ( 1 ) for extracting fluids from a body tissue or organ having an aperture, including a seat ( 26 ) for positioning said tissue, and a pressure means ( 17,22 ) for applying pressure to said tissue while leaving said tissue aperture open for the exit of said fluids. The surface ( 23 ) of the supporting surface of the tissue is shaped as a funnel or cone, so that the apex is directed downward and the base ( 29 ) delimits the supporting surface of the tissue; the apex region being constituted by a hollow cylinder ( 22 ) in order to allow the passage of the umbilical cord of a placenta or of the vessel for the drainage of fluids from the placenta or organ or tissue; the supporting surface being provided so as to avoid producing obstructions or collapse of the surface vessels of the placenta or organ or tissue, so as to avoid hindering the flow of blood or fluid.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to an apparatus for extractingfluids, such as blood or other fluids from a placenta or from otherhuman or animal organs or tissues.

[0002] The apparatus according to the invention is used mainly in thebiological, medical and veterinary field both for diagnostic andtherapeutic purposes and for research purposes, for the extraction ofblood or other fluids from the placenta or another organ or tissue to beused subsequently as a source of cells, molecules or other.

[0003] In the biological, medical and veterinary fields it is necessaryto collect fluids, particularly blood, from organs or tissues orcontainers in general, both for diagnostic and therapeutic purposes andfor research purposes. Two non-limitative examples are: 1. thecollection of blood from masses of tumoral tissue, since the bloodcontained in the tumoral tissue is potentially useful for therapeuticpurposes after appropriate treatment; 2. the collection of blood fromthe placenta during childbirth directly after cutting the umbilicalcord. In this second case, the blood is useful since it contains stemcells, which are hematopoietic precursor cells, that is to say, cellswhich are capable of reconstituting the hematopoietic system andtherefore can be used, if the need arises, for transplanting to the samedonor or to another compatible recipient.

[0004] The procedures currently used to collect placental blood from anumbilical cord are described hereinafter as a typical example of therecovery of fluids from an organ; it is important to note that thereference to this practice is not limitative and is merely an example ofsituations in which it is necessary to collect blood or another fluidfrom tissues, organs or other containers in general.

[0005] Placental blood from the umbilical cord is collected because itcontains hematopoietic stem cells which can be used for transplants. Toallow the collected blood and therefore the recovered cells to be trulyand successfully usable, the following conditions must be met: 1. thelargest possible amount of blood, that is to say, the highest possiblenumber of cells, must be recovered; 2. the collected blood, which isfetal in origin, must not be contaminated by foreign cell populations,such as for example maternal cells; 3. during collection, contact of theblood with the outside (air or other potentially contaminated objects)must be minimized, or the collection procedure must occur in sterileconditions, possibly in a closed environment; 4. the possibility ofhuman error must be minimized.

[0006] Steps of Collection

[0007] a. Before Expulsion of the Placenta.

[0008] Blood is currently extracted from the placenta in the medicalfield, both for diagnostic and therapeutic purposes and for researchpurposes, as follows: during childbirth, directly after the expulsion ofthe newborn child, the umbilical cord is closed (clamped) in two pointsand cut in a point which is intermediate between the two closure points.After cutting, the cut end of the umbilical cord which is connected tothe placenta protrudes freely from the mother's vagina and is availablefor collection operations. Typically, blood is collected in the periodbetween the cutting of the umbilical cord and expulsion of the placenta.During this period, the flow of blood is ensured by the pressuregenerated by uterine contractions, which by compressing the placentafacilitate the outflow of blood through the umbilical cord.

[0009] b. After Expulsion of the Placenta.

[0010] Only a small number of authors reports collection procedureswhich provide for cord blood collection after expulsion of the placentaby placing the placenta on a frame and collecting the blood by gravity.The limited use of collection after expulsion of the placenta iscertainly due to the low yield of collection by gravity and todifficulty in handling the placenta, especially when the sterility ofthe collected blood must be guaranteed.

[0011] Collection Systems

[0012] Collection of placental blood from the umbilical cord in themedical field, both for diagnostic and therapeutic purposes and forresearch purposes, is currently performed with which can be traced backto two categories: “opencircuit” systems and “closed-circuit” systems.Both systems are used for collection both before and after expulsion ofthe placenta.

[0013] a. “Open-Circuit” Systems

[0014] “Open-circuit” systems collect placental blood from the cutumbilical cord in containers which contain anticoagulant. Thiscollection is performed by making the blood flow out directly into thecollection container without connecting the end portion of the cord,which is placed loosely at the inlet of the container.

[0015] Advantages

[0016] The main advantage of this system is the absence of resistancesto flow, since there are no bottlenecks or sudden decreases incross-section of the cord and of its vessels.

[0017] A second advantage is that the three vessels which are present inthe umbilical cord are simultaneously pervious.

[0018] Another advantage of the system is the possibility to express theumbilical cord during collection.

[0019] Disadvantages

[0020] Various scientific papers have demonstrated that “opencircuit”systems do not ensure sterility and are in fact associated with aparticularly high incidence of microbial contaminations. The cut endportion of the umbilical cord in fact has a loose consistency, and sinceit is simply rested on the inlet of the collecting container it caneasily escape from it, consequently contaminating said end portion inaddition to losing blood, which contaminates the outside environment.

[0021] Furthermore, the system inherently (being an “open” system)collects both the blood that flows out of the vessels of the cord andpotentially contaminated liquids which flow along the outer surface ofthe umbilical cord; in particular, the maternal blood which isabundantly present along the outer surface of the placenta flows alongthe cord and mixes with the blood of the umbilical cord.

[0022] This collection system furthermore exposes the blood to the airof the outside environment, thus facilitating contaminations frommicroorganisms which are present in the outside environment.

[0023] Another drawback is the constant need for an operator assigned tokeeping the umbilical cord in the correct position, particularly ifrepeated maneuvers for expressing and cleaning the cord are performed.

[0024] b. “Closed-Circuit” Systems

[0025] Collection is performed by venipuncture of the cut and clampedend of the umbilical cord, after accurately disinfecting the entry pointof the needle. The blood is collected in one or more syringes or indonation pouches.

[0026] Advantages

[0027] With respect to “open-circuit” systems, “closedcircuit” systemsreduce the risks of microbial contamination of the collected blood anddo not require continuous cleaning and disinfection of the cord.

[0028] Another advantage is reduction of the contamination of the samplewith maternal blood or other liquids which flow along the outer surfaceof the cord.

[0029] Disadvantages

[0030] “Closed-circuit” systems entail handling needles and thereforeexpose the operators to the risk of accidental punctures.

[0031] Furthermore, the needle inserted in the umbilical vein is notstably fixed to it and can easily come loose, also in view of the highlydynamic nature of childbirth; this problem is particularly felt ifcollection is continued even after expulsion of the placenta.Accordingly, the continuous presence of an operator is required toensure the correct placement of the needle during the various steps ofcollection.

[0032] If the needle leaves its seat, blood contaminations andaccidental punctures of the operator are possible, and repetition ofvenipuncture is required in order to continue collection.

[0033] Owing to the limited cross-section of two of the three vessels ofthe umbilical cord (the arteries), collection is feasible only on onevessel (the vein), consequently reducing the collection potential.

[0034] The flow of blood is hindered by the sudden decrease incross-section (the needle, no matter how large, can never have the samecross-section as the umbilical vein).

[0035] The needle is inserted in an intermediate segment of theumbilical cord, upstream of the closure region; stasis of the blooddownstream of the insertion point, with a consequent tendency toclotting, is thus inevitable; moreover, the blood which remainsdownstream of the insertion point is not recovered.

[0036] WO-A-92/03180 discloses an apparatus for extracting blood form aplacenta and umbilical cord having a support assembly for holding theplacenta with umbilical cord and a pressure exerting device. The supportassembly includes a rotatable conical receptacle adapted to receive andhold the placenta.

[0037] U.S. Pat. No. 5,053,025 discloses an apparatus for extractingblood from a placenta and an umbilical cord, including a stationaryframe with a rotatable carriermounted thereto and a balloon which isinflated by a compressor, in order to press the placenta.

SUMMARY OF THE INVENTION

[0038] An aim of the present invention is to provide an apparatus forextracting fluids, particularly blood, from a placenta or another organor tissue, whether human or animal, both for diagnostic and therapeuticpurposes and for research purposes, overcoming the drawbacks of theprior art systems.

[0039] An object of the present invention is to provide an apparatuswhich does not require particular experience or training for itsoperation.

[0040] A further object of the present invention is to provide anapparatus safe in use and free from critical points and risks of error.

[0041] A further object of the present invention is to provide anapparatus enabling a health operator with normal experience ofperforming the entire procedure without risks. Still a further object ofthe present invention is to provide an apparatus ensuring optimum yield,repeatable over time.

[0042] Still a further object of the present invention is to provide anapparatus that limits contamination of the environment with blood andother potentially infected material.

[0043] The above aims and other aims that will become apparent to thoseskilled in the art, are achieved by an apparatus as claimed in theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Further characteristics and advantages of the invention willbecome apparent from a reading of the detailed description of apreferred but not exclusive embodiment of the invention illustrated onlyby way of a non-limiting example in the accompanying drawings, wherein:

[0045]FIG. 1 is a view of the upper part, meant to apply uniform orlocalized, pulsed or continuous mechanical pressure on the maternalsurface, hereinafter referenced as the upper surface of the placenta.

[0046]FIG. 2 is a view of a rotating lower cone, which is meant to restand apply uniform or localized, pulsed or continuous mechanical pressurein a radial or centripetal direction on the fetal surface, hereinafterreferenced as the lower surface of the placenta, and on the initialportion of the umbilical cord.

[0047]FIG. 3 is a view of the supporting membrane made of elasticmaterial, which is meant to provide support and transmit uniform orlocalized, pulsed or continuous mechanical pressure, generated by thelower cone, in a radial or centripetal or random orientation, to thelower surface of the placenta and to the initial portion of theumbilical cord.

[0048]FIG. 4 is a view of the machine body, which is meant to providesupport and connect the upper part, the lower resting cone, thesupporting membrane, and any mechanical or pneumatic or electric orother elements which are an integral part of the machine.

[0049]FIG. 5 is a view of a variation of the lower rotating cone, whichis meant to provide support and apply uniform or localized, pulsed orcontinuous mechanical pressure with a radial or centripetal or randomorientation on the lower surface of the placenta and on the initialportion of the umbilical cord.

[0050]FIG. 6 is a view of a variation of the lower rotating cone, whichis meant to provide support and apply uniform or localized, pulsed orcontinuous, radial or centripetal or random mechanical pressure on thelower surface of the placenta and on the initial portion of theumbilical cord.

[0051]FIG. 7 is a schematic general view of the apparatus for applyingpressure to the placenta or organ or tissue and optionally to theproximal portion of the umbilical cord.

[0052]FIG. 8 is a section view according to the section line VIII-VIIIof FIG. 1.

[0053]FIG. 9 is a section view according to the section line IX-IX ofFIG. 2.

[0054]FIG. 10 is a section view according to the section line X-X ofFIG. 5.

[0055]FIG. 11 is a section view according to the section line XI-XI ofFIG. 6.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056] The exemplifying and non-limitative description of the apparatusgiven hereinafter relates to its application to the extraction of bloodfrom the placenta through the umbilical cord after expulsion of theplacenta. The apparatus according to the invention can of course be usedfor collecting blood or other fluids even from other organs or tissues.

[0057] The apparatus according to the invention, generally designated bythe reference numeral 1, as illustrated in FIG. 7, is composed of fourparts:

[0058] An upper part 2, suitable to apply uniform or localized, pulsedor continuous mechanical pressure on the upper part of the placenta.

[0059] The upper part of the exemplifying system described here FIG. 1is constituted by a hollow surface of suitable size and shape, made ofmetal or plastic, polymers or other material suitable for the purpose,which is meant to form a cavity 16 which is closed and sealed by virtueof the suitable positioning of a membrane 17 made of an elasticmaterial, which can be rubber, silicone, polymers or other material. Thepressure inside the chamber is changed and adjusted by means of amanual, electric, mechanical or other system. The pressure variationinside the chamber produces curving of the rubber membrane, which canthus assume a concave, plane or convex shape or the shape of an objectplaced in direct contact therewith. The surface of the membrane can besmooth or discontinuously shaped and may also have the purpose oftransmitting uniform or localized, continuous or pulsed, radially orcentripetally orientated mechanical pressure on the upper surface of theplacenta, said pressure being generated by means of a suitable device.The upper part is connected to the other parts of the machine by virtueof a hinge or joint mechanism or other system 18. A locking system 19 ofthe screw, pin or other type ensures locking of the upper part in theintended position.

[0060] A lower part 3 is adapted to support and apply uniform orlocalized, pulsed or continuous, radially or centripetally orientatedmechanical pressure to the lower surface of the placenta and to theportion of the umbilical cord.

[0061] The lower part of the exemplifying system described herein FIG. 2is constituted by a conical or funnel-shaped element 23 of appropriatesize which ends, at its apex, with a tube 24 having a cross-sectionwhich is suitable to allow the passage of an optional system forconnecting the umbilical cord and the collecting container. The end tubeis in turn inserted and locked in a ball or roller bearing or a bushing,thus allowing the cone to rotate freely about its generating axis. Thebearing or other system is in turn stably fixed to the machine body byvirtue of a suitable support or seat. The inner surface of the cone hasone or more ridges with a suitable cross-section 25 which have a spiralor helical or epicycloidal arrangement and start in the central regionof the cone, proximate to the beginning of the cylindrical or hollowpart.

[0062] A second exemplifying and non-limitative variation of the lowerpart 103, shown in the hypothetical representation of FIG. 5, isconstituted by a series of balls with an eccentric axis or cams whichare arranged so as to roll on the supporting membrane and are rigidlycoupled to the lower cone by virtue of an appropriately shaped(straight, spiral, etc.) axis. This variation ensures a pressure fromabove which is pulsed and concentrated on the lower surface of theplacenta, eliminating radial traction on said placenta.

[0063] Another exemplifying and non-limitative variation 203, shown inFIG. 6, is constituted by raised portions of suitable size and shapewhich are suitable to transmit localized and tangentially-orientatedpressures to the lower surface of the placenta.

[0064] A combination of the above variations is also possible to ensureaxial thrusts with different vectors on the placenta. The lower cone canbe made of plastic or metal or other material suitable for this purpose.

[0065] A supporting membrane 4 is made of elastic material, which actsas a surface for support and transmission of uniform or localized,pulsed or continuous, radially or centripetally orientated mechanicalpressure on the lower surface of the placenta.

[0066] The supporting membrane (FIG. 3) in the exemplifying systemdescribed herein is constituted by an element 20 which has a round shapeand a suitable diameter and thickness, is made of elastic material suchas rubber, silicone, polymers or other material suitable for thepurpose, and is rigidly coupled to the machine body by virtue of a ring21. In the central part, an extension of said membrane or a tube 22 madeof plastic or other suitable material fixed to the membrane and rigidlycoupled to the machine body by virtue of a bracket 28 allows theaccommodation and passage of the umbilical cord and of an optionalconnecting system. In the illustrated example, the membrane is arrangedso that it can rest with a suitable tension on the spiral ridge of thelower cone. The tension of the membrane is adjusted so as to avoidcreating concentrated loads or occlusions of the vessels of theplacenta. In order to optimize this tension, a membrane of suitableconsistency and thickness is used. The function of the supportingmembrane is to transmit the uniform or localized, pulsed or continuous,radially or centripetally or randomly orientated mechanical pressuregenerated by the movement of the lower cone. Another function of thesupporting membrane is to eliminate the lateral and tangent traction ofsaid spiral. Optionally, an appropriate lubricant, such as talc, oil orother minimizes friction between the membrane and the lower cone.

[0067] A machine body 5 acts as support and connection between the upperpart, the lower element, the supporting membrane and any mechanical orpneumatic or electric or other elements which are an integral part ofthe machine.

[0068] The machine body is constituted by a supporting frame ofappropriate shape and size which is made of metal, plastic or othersuitable material and has the function of supporting, connecting andpositioning the upper part, the lower element, the supporting membraneand the mechanical or pneumatic or electric or other elements which arean integral part of the machine. In the drawing (FIG. 4), which is anon-limitative example, there is a lower cone seat 26, a lower conebearing or bushing seat 27, a bracket or support for the lower part ofthe supporting membrane 28, a base for fixing the supporting membrane 29and an access to the lower part of the machine 30.

[0069] The apparatus described up to now, shown schematically in FIG. 7,is used to apply pressure to the placenta or organ or tissue when itbecome available, that is to say, in the case of the placenta, afterexpulsion. The placenta, possibly contained in a suitable container withsoft walls with an absorbent inner surface and an impermeable outersurface, such as to not hinder drainage and have a containment andprotection function, is placed on the supporting membrane 20 so that thematernal surface, hereinafter termed upper surface, is directed upward,and so that the fetal surface, hereinafter termed lower surface, isdirected downward. The umbilical cord, which derives from the lowersurface of the placenta, is accommodated, in its initial segment, in theopening of the tube 22 or in the extension of the membrane, whilst itsend segment, which has an appropriate length, is connected to acollecting system of the open-circuit or closed-circuit type. The idealconfiguration provides for the connection of the end segment of theumbilical cord by virtue of a closed-circuit connecting system whichdoes not compress or in any case does not compromise the flow of blood,keeping open all the vessels located in the umbilical cord, andsimultaneously ensures isolation of the sample from the outsideenvironment and is practical and safe in use. In this firstconfiguration, the machine already allows collection of the placentalblood by gravity, since an accommodation of this kind allows drainageand does not create occlusions on the surface vessels of the lower partof the placenta. The upper part of the machine, which has been kept openup to now to allow to position the placenta on the supporting membrane,is closed and fixed by virtue of appropriate systems. The pressureapplied by the membrane in the inactive position solely by closing theupper part, or the pressure generated by a pneumatic, electric or othersystem inside the sealed chamber is transmitted to the upper surface ofthe placenta by means of the elastic membrane 17. In this configuration,the drainage effect caused by the position of the placenta is improvedby an increase in pressure which is transmitted from the upper surfaceof the placenta to the internal vessels involved in the drainage. Atthis point, a uniform or localized, pulsed or continuous, radially orcentripetally or randomly orientated mechanical pressure is applied tothe lower surface of the placenta; said pressure is generated by therotary movement of the spiral of the lower cone 26 or by another systemand transmitted through the supporting membrane. The combined effect ofthe two possible pressure application systems described above ensures ahigh yield in collection which cannot be achieved with the systems andprocedures currently used.

[0070] The fluid extraction system according to the invention ispractical, simple and safe to use; the entire operation is brief, doesnot require particularly training or skill and does not require theconstant presence of an operator.

1. An apparatus for extracting fluids from a body tissue having anaperture, comprising a seat (16) for positioning said tissue, and apressure means for applying pressure to said tissue while leaving saidtissue aperture open for the exit of said fluids, characterized in thatsaid pressure means comprises at least one elastic membrane (17).
 2. Anapparatus according to claim 1 , characterized in that said elasticmembrane (17) is stretched on a rigid supporting frame (5).
 3. Anapparatus according to claim 2 , characterized in that said rigidsupporting frame (5) is hinged to a case body adapted to contain saidpressure means; said frame being adapted to be left open in an inactiveposition, at right angles to a tissue supporting surface, or closed, inan active position, parallel to the supporting surface; in said closedposition, the plane for connecting the membrane to the frame reachingbeyond the protrusion profile of the tissue that rests on the tissuesupporting surface, thus leaving the central part of the membrane freeto act on said tissue and thus deform and compress the tissue, whichprotrudes from the supporting surface to a different extent.
 4. Anapparatus according to claim 3 , characterized in that said rigid frameis coupled to the membrane (17) so as to delimit a hermetically closedspace, which is connected to a pressure system for applying pressureinside said cavity.
 5. An apparatus according to one or more of thepreceding claims characterized in that said membrane (17) and said frameare shaped so that even in the closed position the membrane only liesproximate to the tissue but does not compress it directly.
 6. Anapparatus according to one or more of the preceding claims,characterized in that said pressure means comprises a plurality ofmembranes surrounding said tissue uniformly.
 7. An apparatus accordingto claim 1 , characterized in that the supporting surface of said tissueis constituted by a circular flat surface which has a central hole whosesize is suitable for the passage of a tissue vessel for draining fluids.8. An apparatus according to one or more of the preceding claims,characterized in that the surface of the supporting surface of thetissue is shaped as a funnel or cone, so that the apex is directeddownward and the base delimits the supporting surface of the tissue; theapex region being constituted by a hollow cylinder in order to allow thepassage of the umbilical cord of a placenta or of the vessel for thedrainage of fluids from the placenta or organ or tissue; the supportingsurface being provided so as to avoid producing obstructions or collapseof the surface vessels of the placenta or organ or tissue, so as toavoid hindering the flow of blood or fluid.
 9. An apparatus according toone or more of the preceding claims, characterized in that, thesupporting surface of the placenta or organ or tissue is free to rotateabout a central axis.
 10. An apparatus according to one or more of thepreceding claims, characterized in that the surface for supporting thetissue has raised portions.
 11. An apparatus according to one or more ofthe preceding claims, characterized in that the surface for supportingthe tissue has ridges which have a spiral or helical or epicycloidalshape and start in the central region of the cone, proximate to thebeginning of the cylindrical or hollow part.
 12. An apparatus accordingto one or more of the preceding claims, characterized in that thesurface for supporting tissue has balls or cams which are fixed to thesupporting surface, below the elastic membrane and can rotate freelyabout their own axis; said balls or cams being moved by the frictionbetween the surface of the balls or cams and the elastic membrane. 13.An apparatus according to one or more of the preceding claims,characterized in that the pressure can also be applied in the connectingpart between the supporting surface of the tissue and a cylinder forcontaining the umbilical cord or outflow vessel for fluids and alongsaid cylinder for containing the outflow vessel.
 14. An apparatusaccording to one or more of the preceding claims, characterized in thatthe positive pressure is also applied along the umbilical cord or exitvessel.
 15. An apparatus according to one or more of the precedingclaims, characterized in that pressure is applied to the outside of thetissue with the application of negative pressure or suction in theregion for connection of the umbilical cord or outflow vessel.
 16. Anapparatus according to one or more of the preceding claims,characterized in that said vessel is connected by means of a suitableconnector to a container for collecting the fluid, so as to form aclosed collection system which allows transfer of the fluid from thetissue to the collection container by means of a closed system.
 17. Anapparatus according to one or more of the preceding claims,characterized in that the tissue is confined in a partially or fullyhermetic container.
 18. An apparatus according to one or more of thepreceding claims, characterized in that said hermetic container has anabsorbent internal surface and an impermeable outer surface.
 19. Anapparatus according to one or more of the preceding claims,characterized in that the pressure is applied to the tissue by a closedchamber inside which said umbilical cord or fluid outflow vessel isconnected to a fluid collection container by means of a system whichseals the chamber from the outside environment.